MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B1060-060

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Folded (2630)

Patient Problem Unspecified Infection (1930)

Event Date 01/13/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the mid superficial femoral (sfa) artery with moderate tortuosity and heavy calcification.It was noted that the sfa was occluded and there was a lot of calcification.The 6 x 60 mm armada balloon catheter was prepared per the instructions for use and advanced to the lesion without issue.The balloon was inflated two times; however, this did not manage to suppress all the calcification.During the third inflation with the balloon, a balloon rupture occurred.The inflation pressures are unknown, but noted to be not high.An attempt was made to remove the armada balloon catheter; however, resistance was noted with the sheath, and the balloon began to bunch up on the sheath.When the balloon catheter was pulled more, the distal end of the balloon broke loose from the balloon catheter.The entire balloon was separated from the catheter.The separated portion traveled distal in the sfa.The balloon catheter was then removed and a cut down procedure was performed.Forceps were used to remove the distal portion of the balloon catheter from the anatomy.The patient was sent to revascularization for treatment of the lesion, and needed to stay for two days in the hospital instead of an immediate discharge.It was noted that the patient developed a wound infection at the cut down site which is partially necrotic and currently being treated with antibiotics.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The balloon rupture, bunching, and separation were able to be confirmed.The difficulty removing was not tested due to the condition of the returned unit.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3624901
• MDR Text Key: 4209363
• Report Number: 2024168-2014-00791
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: B1060-060
• Device Lot Number: 30807G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHEATH: TERUMO 6FR
• Patient Outcome(s): Hospitalization; Required Intervention